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TThe Food and Drug Administration on Wednesday granted emergency use clearance for Pfizer and BioNTech’s Covid-19 vaccine booster, although for now the FDA has said use of the booster should be limited to people from over 65, adults 18 and over at high risk of severe Covid, and those, such as healthcare workers, are at higher risk of infection as a result of their work. This list includes teachers.
With the agency’s decision, the Biden administration takes one step closer to implementing its plan to start offering booster shots to Americans, a campaign it had announced would begin this week. At this point, however, only boosters using the Pfizer vaccine can be considered.
“This pandemic is dynamic and evolving, with new data on the safety and efficacy of vaccines becoming available every day,” Acting FDA Commissioner Janet Woodcock said in a statement announcing the authorization. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to assess the rapidly evolving science and keep the public informed. . “
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While the FDA decision means the boosters will not currently be available to a population as large as the Biden administration had hoped, the groups shown could encompass a large portion of the adult US population.
The CDC estimates that there are approximately 53 million Americans aged 65 and over. Between 17 and 20 million people are healthcare workers. And up to 100 million people are estimated to have medical conditions that put them at increased risk of serious illness if they contract Covid.
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The FDA statement said that a wide range of essential workers – “medical professionals, teachers and daycare staff, grocers and those in homeless shelters or prisons, among others” – should be eligible for recalls.
One group that was not selected was the 16 and 17 year olds. Pfizer had requested the recall for anyone aged 16 and over, but provided no data to support the safety of a third injection in anyone under the age of 18. The FDA advisory committee has vigorously opposed their inclusion and the recall authorization is for people 18 years of age and older.
Pfizer and BioNTech had requested a full license for their recall, which they hoped would be made available to anyone who had previously received their vaccine. They proposed that the third hit be given at least six months after the second hit in the series.
But in a rigorous meeting last Friday, a panel of experts that advises the FDA on vaccines voted against recommending this wide use, with members arguing that there is not enough evidence to support the claim that all people 16 years of age and over who have received the Pfizer vaccine should be boosted six months after their second injection. While the FDA is not required to follow the advice of the Advisory Committee on Vaccines and Related Biologics – known as VRBPAC for short – it generally does. And he has in this situation.
The committee voted 16-2 against boosters for all at this point. But he voted 18 to 0 in favor when asked if the evidence supports giving a third dose to people over 65 and to people at high risk of developing severe Covid, if they get it. sickness. The question did not specify who was considered to be at high risk, although there was a discussion of people who are frequently exposed to Covid, such as healthcare and frontline workers, and people with problems. health issues like obesity and diabetes which have been linked to higher risk. serious illness.
Clarifying who should be offered Pfizer booster doses at that time will now be the responsibility of the Centers for Disease Control and Prevention’s vaccine expert group, the Advisory Committee on Immunization Practices. He will vote on Thursday on whether to advise the CDC to recommend the use of the jab booster, and what groups of people should be offered it at this point. CDC Director Rochelle Walensky will then have to approve ACIP’s recommendations. Like the FDA and its Vaccine Advisory Committee, the CDC director is not obligated to follow ACIP’s advice, but almost always does.
The group met all day on Wednesday to discuss data on the effectiveness of the Covid vaccine and evidence of diminished protection, among other issues. The meeting reported issues that ACIP will likely find difficult when discussing the booster recommendations on Thursday, including the fact that some of the people who may soon need a booster vaccine were not initially vaccinated with the booster. Pfizer vaccine. The Moderna and Johnson and Johnson vaccine boosters have not yet been authorized.
Several ACIP members asked if they would be able to recommend that those eligible for a booster be allowed to receive the Pfizer vaccine, regardless of the vaccine they initially received. Another questioned whether it made sense to delay the start of the recall campaign until all three boosters have been cleared by the FDA.
“I don’t want to endanger anyone,” said Sarah Long, professor of pediatrics at Drexel University College of Medicine. “At the same time, it will be very, very difficult to have a little less than half of the population who are eligible. [for a booster] be able to receive one.
Molly Howell, a non-voting member of the committee that represents the Association of Immunization Managers, warned that having a recall of just one of the companies supplying vaccines to the United States would create real logistical challenges, especially when it comes to giving booster shots. residents of retirement homes.
“In North Dakota, when we looked at our long-term care facilities, the vast majority had a mix of people who needed Moderna and Pfizer,” said Howell, who is also responsible for the Vaccination Program. North Dakota Department of Health. “I don’t know if it’s realistic to come back with different brands. “
Howell noted that when ACIP voted to recommend that immunocompromised people receive a third dose, the committee said that if the brand of vaccine a person received for dose 1 and dose 2 was not available , she could be vaccinated with another product. “I think that would be very helpful, especially when we are talking about vaccination in a long-term care facility. “
Doran Fink, of the FDA’s Office of Vaccines Research and Review, said the agency currently does not have enough data to tell him that a booster dose with a different vaccine would be as effective in getting a third one. dose of the same vaccine.
“I really appreciate the concerns about the flexibility and timing of availability of other vaccines authorized for a booster dose,” Fink said, suggesting he would consult with colleagues at the FDA and come back with a response on Thursday.
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